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Valsartan to Prevent Left Ventricle Remodeling in Pacemaker Patients

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2013 by Medical University of Silesia
Sponsor:
Collaborator:
Polpharma Pharmaceutical Company
Information provided by (Responsible Party):
Andrzej Tomasik MD PhD FESC, Medical University of Silesia
ClinicalTrials.gov Identifier:
NCT01805804
First received: March 2, 2013
Last updated: March 4, 2013
Last verified: March 2013

March 2, 2013
March 4, 2013
March 2013
December 2013   (final data collection date for primary outcome measure)
change in echocardiographically assessed left ventricle dimensions and left ventricle function [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01805804 on ClinicalTrials.gov Archive Site
  • change in plasma level of matrix metalloproteinase 9 [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
  • change in plasma level of NTproBNP [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
  • change in atrial arrhythmia burden assessed from pacemaker memory [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
  • change in the rate of occurrence of any major adverse cardiovascular event [ Time Frame: 2 weeks, 3 months, 6 months, 9 months and 12 months ] [ Designated as safety issue: Yes ]
  • change in plasma level of tissue necrosis factor alpha [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
  • change in plasma level of tissue inhibitor of matrix metalloproteinase 3 [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
  • change in distance walked during six minute walking test [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Valsartan to Prevent Left Ventricle Remodeling in Pacemaker Patients
Is There a Possibility to Pharmacologically Prevent Left Ventricle Remodeling in Patients With Pacemaker? Randomized, Placebo Controlled Blinded Study to Assess the Efficacy of Valsartan to Prevent Left Ventricle Remodeling in Patients With Dual Chamber Pacemaker

Dual chamber pacing is known to induce left ventricle remodeling and may eventually lead to heart failure. The investigators aim to test hypothesis that valsartan started immediately after dual chamber pacemaker implantation will prevent left ventricle remodeling in twelve months long follow up in comparison with placebo. Echocardiographic assessment of left ventricle remodeling will be correlated with plasma activity of matrix metalloproteinases and their tissue inhibitors, indices of functional capacity such as plasma level of NTproBNP and distance in meters during six minute walking test.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
First Time Dual Chamber Pacemaker Implantation
Drug: placebo/valsartan
Other Names:
  • Valsartan
  • Other names:
  • Diovan
  • Axudan
  • Vanatex
  • Placebo Comparator: Placebo
    Placebo pills to match valsartan tablets administered once daily
    Intervention: Drug: placebo/valsartan
  • Experimental: valsartan 80mg daily
    Intervention: Drug: placebo/valsartan
  • Experimental: valsartan 160mg daily
    Intervention: Drug: placebo/valsartan

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
December 2014
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • informed written consent
  • age ≥ 18 years
  • first time pacemaker implantation for trifascicular block, atrioventricular second or third degree block
  • left ventricle ejection fraction ≥ 40%

Exclusion Criteria:

  • significant valvular heart disease
  • ischaemic heart disease requiring further revascularization
  • symptomatic hypotension
  • orthostatic disorders
  • pregnancy, breast feeding, child bearing potential
  • previous use of angiotensin receptor blocking agents
  • known hypersensitivity to valsartan
  • significant liver disorders
  • significant renal disorders, including renal artery stenosis
  • hyperaldosteronism
  • chronic use of nonsteroid antiinflammatory drugs
  • chronic use of lithium salts
  • Patient's reluctance or disability to obey protocol and/or follow the scheduled visits
  • any significant disease to reduce the expected life duration < 12 months
  • participation in any other trial within the last 30 days before randomization
  • any situation that would put more risk on patient
Both
18 Years and older
No
Contact: Beata Bialkowska, MD 0048323732372 beata.bialkowska@sum.edu.pl
Poland
 
NCT01805804
01/2012, KNW-1-154/P/2/0
No
Andrzej Tomasik MD PhD FESC, Medical University of Silesia
Medical University of Silesia
Polpharma Pharmaceutical Company
Study Director: Ewa Nowalany-Kozielska, MD PhD Associate Professor Medical University of Silesia
Medical University of Silesia
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP